Such boards are formally designated to approve (or reject), monitor, and review biomedical and behavioral research involving humans, and they are legally required in some countries under certain specified circumstances.
Most countries use some form of IRB to safeguard ethical conduct of research so that it complies with national and international norms, regulations or codes.
A key goal of IRBs is to protect human subjects from physical or psychological harm, which they attempt to do by reviewing research protocols and related materials.
Formal review procedures for institutional human subject studies were originally developed in direct response to research abuses in the 20th century.
The result of these abuses was the National Research Act of 1974 and the development of the Belmont Report, which outlined the primary ethical principles in human subjects review; these include "respect for persons", "beneficence", and "justice".
[3] These regulations define the rules and responsibilities for institutional review, which is required for all research that receives support, directly or indirectly, from the United States federal government.
IRBs are responsible for critical oversight functions for research conducted on human subjects that are "scientific", "ethical", and "regulatory".
In addition to registering its IRB with the OHRP, an institution is also required to obtain and maintain a Federalwide Assurance or FWA, before undertaking federally funded human research.
[7] This DoD Addendum includes further compliance requirements for studies using military personnel, or when the human research involves populations in conflict zones, foreign prisoners, etc.
These categories include: Generally, human research ethics guidelines require that decisions about exemption are made by an IRB representative, not by the investigators themselves.
[4][5] Numerous other countries have equivalent regulations or guidelines governing human subject studies and the ethics committees that oversee them.
The United States Department of Health and Human Services maintains a comprehensive compilation of regulations and guidelines in other countries, as well as related standards from a number of international and regional organizations.
Originally, IRBs were simply committees at academic institutions and medical facilities to monitor research studies involving human participants, primarily to minimize or avoid ethical problems.
[14] When a full review is required, a majority of the IRB members must be present at the meeting, at least one of whom has primary concern for the nonscientific aspects of the research.
Numerous complaints by investigators about the fit between the federal regulations and its IRB review requirements as they relate to social science research have been received.
[19] Researchers have tried to determine under what instances participants are more likely to read informed consent forms, and ways to improve their efficacy in the social sciences.
[23] In 2017, the federal government announced that effective January 2018, the regulations would no longer cover "Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information that focus directly on the specific individuals about whom the information is collected.
[26][27][28] One theme is data breaches, but another with high difficulty is potentially dangerous predictive analytics with unintended consequences, via false-positives or new ways to invade privacy.
[27] It also gave an example of potential privacy invasion and government repression in which machine learning was used to build automated gaydar, labeling strangers as "probably gay" based on their facial photographs.
[27] Analogies with phrenology[26] and Nazis identifying people as "probably part-Jewish" based on facial features have been made to show what can go wrong with research whose authors may have failed to adequately think through the risks of harm.
[34] In 2009 the US Government Accountability Office (GAO) set up a series of undercover tests to determine whether the IRB system was vulnerable to unethical manipulation.
The product was deliberately formulated to match some "significant risk" criteria of the FDA and was described by GAO as a "gel that would be poured into a patient's stomach after surgery to collect the bits and pieces left over from an operation."